Positioning and adjusting two axis joint implants

ABSTRACT

An inserter connects to an implant which has two rotatable actuators for adjusting two different parameters of the insert. The inserter has a handle and a frame extending from the handle. A hollow tube is supported by the frame and has an end that can be connected and disconnected from the implant when the tube is rotated. A stem is passed through the tube, and another stem is supported by the frame. Each of the stems has an end that is connectable to an actuator of the implant, and an opposite end connectable to a tool driver. When the tool driver rotates a stem connected to the implant, a parameter of the implant is changed. The stems can be removed for cleaning or for replacement with a different type of stem. The two parameters can be a height of different sides of the implant.

CROSS-REFERENCE TO RELATED APPLICATION(S)

The present application is a continuation application of U.S. patentapplication Ser. No. 16/558,364 filed on Sep. 3, 2019 (published as U.S.2021-0059839) which is hereby incorporated by reference in its entiretyfor all purposes.

FIELD OF THE DISCLOSURE

The disclosure relates to a system and method for positioning andsubsequently adjusting joint implants, and in particular, to insertingand adjusting an implant that is adjustable over two axes.

BACKGROUND OF THE DISCLOSURE

A common procedure for handling pain associated with intervertebraldiscs that have become degenerated due to various factors such as traumaor aging is the use of intervertebral fusion devices for fusing one ormore adjacent vertebral bodies. Generally, to fuse the adjacentvertebral bodies, the intervertebral disc may first be partially orfully removed. Typically, an intervertebral fusion device may then beinserted between neighboring vertebrae to maintain normal disc spacingand restore spinal stability, thereby facilitating an intervertebralfusion.

There are a number of known conventional fusion devices andmethodologies in the art for accomplishing the intervertebral fusion.These include screw and rod arrangements, solid bone implants, andfusion devices which include a cage or other implant mechanism which,typically, is packed with bone and/or bone growth inducing substances.These devices are implanted between adjacent vertebral bodies in orderto fuse the vertebral bodies together, alleviating the associated pain.

However, there are drawbacks associated with known conventional fusiondevices and methodologies. For example, two important factors inintervertebral fusion may be the anterior (lordotic) angle adjustmentand posterior height adjustment. The lordotic angle may be important inrestoring sagittal balance while the posterior height may aid inrestoring disc height and indirect decompression of the neural foramen.While convention fusion devices may allow for in-situ expansion, they donot allow for the lordotic angle and posterior height to be adjustedin-situ independently of one another.

SUMMARY OF THE DISCLOSURE

In an embodiment of the disclosure, a device for inserting and adjustinga therapeutic implant having two rotatable actuators, comprises a bodyforming a handle portion and having a frame connected to and extendingfrom the handle portion; a tube defining a distal end and an opposedproximal end, having a hollow central bore, supported by the frame toextend away from the body, and having an engagement end at the shaftdistal end that is releasably engageable with the implant; first andsecond stems each having a distal end including a tool end engageablewith a rotatable actuator of the implant, having a proximal endrotatable to cause rotation of the distal end to thereby rotate therotatable actuator of the implant when the tool end is engaged with theimplant; the first stem being rotatably and slideably disposed withinthe hollow central bore of the tube; and the second stem being rotatablyand slideably supported by the frame.

In variations thereof, the engagement end at the shaft distal end beinga threaded surface mateable with threads of the implant; the tubefurther includes a peripheral external gear at a proximal end, thedevice further including a rotatable ring having an internal peripheralgear mateable with the peripheral external gear of the tube, therotatable ring rotatable to cause rotation of the tube to cause theengagement end of the shaft distal end to engage or disengage with theimplant; and/or each of the first and second stems includes a springbearing upon the body and the stem to urge the stem away from the handleportion of the body and into engagement with the implant when theimplant is engaged with the tube.

In further variations thereof, each of the first and second stems has asleeve concentrically surrounding the stem within the handle portion,the spring concentrically surrounding the stem and inside the sleeve,the sleeve and spring retained within the handle portion by a distal anda proximal block; the first and second stems are releasably engageablefrom the body by moving at least the proximal block; and/or the springis retained upon the stem by a stem collar at a distal end of the springand a flange of the sleeve at a proximal end of the spring, the stem,spring, and collar thereby being mutually connected.

In yet further variations, thereof, the proximal block includes twoelongated openings each forming an overlapping small bore and largebore, a sleeve each passable through a large bore and not a small bore,the proximal block movable to align each of either the small bores orthe large bores with a sleeve; the distal block slideable within thehandle portion to bear upon the sleeve of each stem, and to thereby pushthe respective sleeve, spring, and stem through the large bore and outof the body when the proximal block is moved to align each of the largebores with a sleeve; and/or the distal block is resiliently mountedwithin the handle portion to align the small bores with the stems in aresting position, and movable by pressing a button formed at an end ofthe distal block to a release position in which the large bores arealigned with the stems; and/or each of the stems are independentlyrotatable.

In other variations, a resiliently mounted cam is associated with one ofthe distal block and the body and a detent associated with the other ofthe distal block and the body, the cam and detent releasably engageableas the distal block is moved to define a locked position and a releaseposition; the cam is a ball plunger; the frame includes at least twochannels, one of the at least two channels supporting the tube, anotherof the at least two channels supporting the second stem; the handleportion including two proximal apertures each communicating with aproximal end of a stem; and/or the stems are reversibly removable.

In another embodiment of the disclosure, a device for inserting andadjusting a therapeutic implant having two rotatable actuators, theimplant having a threaded connector, where the device comprises ahandle; a frame including at least two channels, the frame having aproximal end connected to the handle and a distal end extending awayfrom the handle; a tube defining a distal and an opposed proximal end,having a hollow central bore, supported by the frame to extend away fromthe body, having threads at the shaft distal end that is releasablyengageable with the threaded connector of the implant, and having anexternal peripheral gear at the proximal end; first and second stemseach having a distal end including a tool engagement end engageable witha rotatable actuator of the implant, having a proximal end with a toolengagement rotatable to cause rotation of the distal end to therebyrotate the rotatable actuator of the implant when the tool engagement isengaged with the implant; the first stem being rotatably and slideablydisposed within the hollow central bore of the tube, the first stemindependently rotatable with respect to the tube; the second stem beingrotatably and slideably supported by the frame; and a ring rotatablyconnected to the handle and including an internal peripheral gearmateable with the external peripheral gear of the tube, the tube therebyrotated by rotation of the ring.

In a variation thereof, each of the first and second stems includes aspring bearing upon the handle and the stem to urge the stem away fromthe handle portion of the body and into engagement with the implant whenthe implant is engaged with the tube.

In a further embodiment of the disclosure, a method of inserting andadjusting a therapeutic implant having two rotatable actuators eachoperable to change a parameter of the implant, comprises connecting theimplant to an inserter having: a body forming a handle portion andhaving a frame connected to and extending from the handle portion; atube defining a distal end and an opposed proximal end, having a hollowcentral bore, supported by the frame to extend away from the body, andhaving an engagement end at the shaft distal end that is releasablyengageable with the implant; first and second stems each having a distalend including a tool end engageable with a rotatable actuator of theimplant, having a proximal end rotatable to cause rotation of the distalend to thereby rotate the rotatable actuator of the implant when thetool end is engaged with the implant; the first stem being rotatably andslideably disposed within the hollow central bore of the tube; and thesecond stem being rotatably and slideably supported by the frame; androtating the first and second stems to change two parameters of theimplant.

In a variation thereof, rotating the first and second stems causes adifferent change in height of two sides of the implant relative to eachother, to thereby define a therapeutic lordotic angle.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present disclosure, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 depicts a perspective side view of an inserter in accordance withthe disclosure;

FIG. 2 depicts a perspective top view of an inserter in accordance withthe disclosure;

FIG. 3 depicts an end view of an end of the inserter of FIG. 1 which isinserted into the body;

FIG. 4 depicts an end view of an end of the inserter of FIG. 1 which isheld;

FIG. 5 depicts a perspective view of an implant insertable andadjustable with the inserter of the disclosure;

FIG. 6 depicts a bottom perspective view of the inserter of FIG. 1, withstems removed;

FIG. 7 depicts a bisected cross-section of an end of the inserter ofFIG. 1 and the implant of FIG. 5;

FIG. 8 depicts a top perspective view of the inserter of FIG. 1, withstems removed;

FIG. 9 is a diagram of an implant insertable and adjustable by theinserter of FIG. 1, illustrating a lordotic angle achievable inaccordance with the disclosure;

FIG. 10 is an exploded perspective view of a gear configuration of theinserter of FIG. 1;

FIG. 11 is an alternative perspective view of a gear configuration ofthe inserter of FIG. 1;

FIG. 12 depicts a perspective view of a handle assembly of the inserterof FIG. 1, separated from a frame assembly;

FIG. 13 depicts a perspective view of a plunger ball of the inserter ofFIG. 1, as further shown in FIG. 14;

FIG. 14 depicts an exploded view of the handle portion of the inserterof FIG. 1, with a slide assembly removed;

FIG. 15 depicts an exploded view of the handle portion of the inserterof FIG. 1, with a retaining block assembly removed;

FIG. 16 depicts a bisected cross-sectional view of the handle portion ofthe inserter of FIG. 1;

FIG. 17 depicts a bisected cross-sectional view of the handle portion ofthe inserter of FIG. 1, and a portion of the frame, with the stems inplace;

FIG. 18 depicts a perspective view of an inserted end of the inserter ofFIG. 1;

FIG. 19 is a perspective view of the handle portion of the inserter ofFIG. 1, with the body removed;

FIG. 20A depicts a bisected cross-sectional view of the handle depictionof the inserter of FIG. 1, before engagement of the stems with animplant;

FIG. 20B depicts the inserter of FIG. 20A, after engagement of the stemswith an implant;

FIG. 21A depicts a side view of the inserter of FIG. 1 prior to releaseof stems; and

FIG. 21B depicts a side view of the inserter of FIG. 1 after release ofstems.

DETAILED DESCRIPTION OF THE DISCLOSURE

As required, detailed embodiments are disclosed herein; however, it isto be understood that the disclosed embodiments are merely examples andthat the systems and methods described below can be embodied in variousforms. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the present subject matter in virtually anyappropriately detailed structure and function. Further, the terms andphrases used herein are not intended to be limiting, but rather, toprovide an understandable description of the concepts.

The terms “a” or “an”, as used herein, are defined as one or more thanone. The term plurality, as used herein, is defined as two or more thantwo. The term another, as used herein, is defined as at least a secondor more. The terms “including” and “having,” as used herein, are definedas comprising (i.e., open language). The term “coupled,” as used herein,is defined as “connected,” although not necessarily directly, and notnecessarily mechanically. Headings are provided for the convenience ofthe reader and are not to be construed as limiting.

Introduction

A spinal fusion is typically employed to eliminate pain caused by themotion of degenerated disk material. Upon successful fusion, a fusiondevice becomes permanently fixed within the intervertebral disc space.With reference to FIGS. 5 and 9, an example of an expandable fusiondevice, or implant 5500 that can be inserted and adjusted in accordancewith the disclosure is shown between adjacent vertebral bodies 15 and20. Implant 5500 may be implanted between two adjacent vertebral bodies15 and 20 in any section of the spine, including the cervical, thoracic,lumbar, and sacral vertebral sections. More than one expandable fusiondevice 10 may be implanted within the body, for example, betweensuccessive or separated vertebrae. As illustrated, implant 5500 engagesthe endplates 25 and 30 of the adjacent vertebral bodies 15 and 20 and,in the installed position, maintains normal intervertebral disc spacingand restores spinal stability, thereby facilitating an intervertebralfusion. An implant 5500 can be manufactured from a number of materialsincluding titanium, stainless steel, titanium alloys, non-titaniummetallic alloys, polymeric materials, plastics, plastic composites,PEEK, ceramic, and elastic materials.

Two important intervertebral implant parameters for addressing spinalpathologies include lordotic angle and posterior height. The lordoticangle is important, for example, for restoring sagittal balance, whilethe posterior height aids, at least, in restoring disc height andindirect decompression of the neural foramen. Until the instantdisclosure, these parameters could not be adjusted in-situ independentlyof each other, and particularly without repositioning instruments withinthe body. In accordance with the disclosure, the medical practitionercan now manipulate both the lordotic angle and height of the implant insitu, without repositioning a tool, to best fit the implant to desiredpatient anatomy, to thereby more likely obtain a favorable therapeuticresult while introducing the least amount of tissue disturbance.

With reference to FIG. 9, expansion of the implant 5500 may becontrolled so that the anterior height H_(a) and the posterior heightH_(p) may be independently controlled. By way of example, the expandablefusion device 10 may have independent anterior expansion and posteriorexpansion mechanisms, each controlled by a separate actuator, shown herewith separate tri-lobe and slotted actuator engagements 5552, 5554,although other engagement types can be employed. By separate control ofanterior expansion and posterior expansion, an operator may adjust theexpandable fusion device 10 to provide a desired amount of posteriorheight H_(p) and lordotic angle θ (shown in FIG. 9). Alternativelystated, the implant is adjusted along two separate axes. Those ofordinary skill in the art will appreciate that the lordotic angle θ isdependent on the anterior height H_(a) and posterior height H_(p) ofimplant 5500. In some embodiments, expansion on the anterior side 35 andthe posterior side 40 may also be performed simultaneously to maintain alordotic angle θ with only changing the anterior height H_(a) and theposterior height H_(p) at the same rate.

Implant Engagement

The disclosure provides an inserter 800 that reversiblyengages/disengages from the implant 5500 (FIGS. 5, 7), or implant 10(FIG. 9) and which can expand and contract the implant with respect tolordotic angle and height, or any two adjustable parameters of theimplant. A cannulated, geared, threaded tube 802 is actuated by aninternal ring gear 806 of ring 804 (FIG. 11) for threading and securingthe inserter to the implant. The proximal portion 810 of tube 802 has aperipheral gear 808 which matingly engages with an internal ring gear806 which is concentrically connected to rotatable ring 804 that can beknurled as shown to improve grip by a hand of a user. Rotatable ring 804is rotatably mounted to a body 818 forming a handle graspable by a userof inserter 800. When rotatable ring 804 is rotated, tube 802 rotatesthrough engagement of gears 806, 808. The distal end 812 of shaft 802(FIG. 18) has an external thread 814 which is reversibly engaged withmating threads of threaded aperture 635 of implant 5500 (FIG. 5), tosecurely and reversibly fasten inserter 800 to implant 5500. Tube 802 isrotatably supported by a first channel 824 which can be formed in one ormore sections (each marked as 824 in the figures). Alternatives torotatable ring can include, as examples, directly rotating peripheralgear 808, or other actuator connected to tube 802, for example directlydriving an end of tube 802 with a tool engagement.

While distal end 812 is shown with threads 814, other reversible typesof engagement are possible, such as a twist-lock or magnetic connection,for example. One or more tabs 876 (FIG. 18) or other mating engagementcan additionally be provided at a distal end of frame 868, which engageor mate with a corresponding structure on implant 5500, to providealignment and additional stability.

Implants 5500 and 10 are described in detail in U.S. Pat. No.10,052,215, the contents of which is incorporated by reference herein.Herein, implant 5500 is referenced, however it should be understood thatthe disclosure can be carried out using any implant with two actuatorsengageable by inserter 800, including implant 10 or other implants ofthe cited reference, or other known or hereinafter devised implants.

Implant Actuation

A distal end 828 of an elongated stem 820 forming a driver is advancedthrough the bore of tube 802 to engage with a mating screw 5552 (75 inFIG. 9) or other actuator of implant 5500. A second guide channel 826,which may be formed in one or more sections (each marked as 826 in thefigures) enables insertion of a second elongated stem 822, which isengageable at a distal end 830 with a second mating screw 5554 (80 inFIG. 9) or other actuator of implant 5500. Channels 824 and 826 can besupported by a frame 868 that extends from and is unitary with body 818,or is separable as shown in the figures, and is connected to body 818,for example using threaded fasteners 866 (FIG. 19).

A separable driver or other tool (not shown) can be engaged with aproximal end 832 or 834 of stem 820 or 822, each of which is providedwith a tool engagement mateable with the separable driver. In theembodiment shown, and as described further elsewhere herein, stem 820 or822 is pushed further into body 818 when implant 5500 is engaged withimplant 5500 (FIG. 20B). The separable driver tool end may be insertedinto body 818 to engage stem 820 or 822 when implant 5500 is engaged.

Insertion stems 820, 822 can be provided with any type of driverengagement at distal end 828, 830, respectively, which mates withimplant actuators 5552, 5554, and any type of driver engagement atproximal ends 832, 834, with mate with the separable driver, such as hexor torx, or the tri-lobe tips shown.

Stems 820, 822 are rotatable in either direction to each increase ordecrease a parameter of implant 5500, such as independently adjusting aheight of each side of implant 5500 to affect both an overall height ofthe implant as well as a lordotic parameter. When a desired amount ofadjustment has been made, either or both of stems 820, 822 can beretracted away from the implant, and the tube can be unthreaded from theimplant, after which the inserter end may be completely removed from thebody.

In accordance with the disclosure, independent control of lordotic angleand posterior height allows the surgeon to better customize the shapeand fit of the implant to the patient anatomy. This is unlike knownimplants where manipulation of both the posterior height and angle isnot possible. A tailored fit of both height and angle can help reducethe risk of subsidence and provide an overall better post-surgicalresult for the patient. The insertion instrument of the disclosurefacilitates correct use of variations of implant 5500 which enable suchseparate control.

With respect to the embodiment of FIG. 55 et seq. of U.S. Pat. No.10,052,215 (FIGS. 5 and 7 herein, with FIG. 9 illustrating analternative implant), and similar implants, in particular, the inserterof the disclosure provides the additional advantage of preventingundesired kyphosis. More particularly, because implant 5500 can bethreaded to the inserter via threads at 5534 on the posterior side,inserter 800 can prohibit greater expansion of the posterior side thanthe anterior side, ensuring implant 5500 is not inserted at a kyphoticangle. As the anterior side of implant 5500 is expanded by rotation ofstem 822, the proximal ramp of implant 5500 is drawn toward the distalside of implant 5500. This leave space for the same to occur with theposterior side of implant 5500. However, on the posterior side, as theproximal ramp moves closer to the distal side of the implant, theinserter moves with it because they are firmly attached via threads 814.As the posterior side height is brought to the height of the anteriorside, the distal end 838 of inserter 800 is drawn closer to the anteriorside of implant 5500 until it abuts on a surface of the proximal side ofimplant 5500. Accordingly, further expansion of the posterior side isnot possible until the anterior side is expanded further.

Positive Stem Engagement

With reference to FIGS. 19-20, in particular, stems 820, 822 areslidably mounted within tube inserter 800 and channels 826,respectively, to enable engagement and disengagement with implantactuators 5552, 5554. Stems 820, 822 each further slide within a sleeve840 which is disposed within body 818. During use of inserter 800,sleeves 840 are prevented from moving within body 818 by contact withrelease assemblies 850, 880, which are positioned on opposite ends ofeach sleeve 840, as explained further elsewhere herein.

Sleeves 840 each house a spring 844. Springs 844 are each confinedwithin a sleeve 840 by a stop flange 846 connected to a proximal end ofsleeve 840, and a collar 848 disposed about each of stems 820, 822, eachstem axially disposed within a sleeve 840 and a spring 844. As a result,as stems 820, 822 are moved axially by contact with implant 5500 througha sleeve 840, spring 844 is compressed, urging stem 820 or 822 in acounter direction towards implant 5500, for example from the position ofFIG. 20A to the position of FIG. 20B. Accordingly, distal ends 820 and830 are maintained within mating engagement with actuators 5552, 5554 ofimplant 5500 as implant 5500 is manipulated into position andsubsequently adjusted. In addition, stop flange 846 and collar 848engage the stem with the sleeve 840 and spring 844.

In addition to providing a positive engagement between stems 820, 822and implant 5500, springs 844 enable a given set of stems 820, 822 towork with implants of differing configurations. For example, actuators5552, 5554 may be positioned closer or farther from the threadedengagement formed between external thread 814 and threaded aperture 635of implant 5500. Springs 844 enable stems 820, 822 to axially advance asneeded to engage actuators 5552, 5554, while maintaining the samepositive engagement regardless of such distance. Springs 844 areselected to provide a desired engagement force throughout a range ofcontact distances anticipated.

Stem Removal/Replacement

The disclosure provides for replacing stems 820, 822, for example toinclude longer or shorter stems, or stems with different endengagements, and to clean the stems and associated components. Withreference in particular to FIGS. 12-17, 19, and 21, two releaseassemblies, slide release assembly 850 and stop release assembly 880,cooperate to retain stems 820, 822, sleeves 840, and springs 844, withininserter 800.

Stop release assembly 880 includes a stop button 882 accessible on anexternal surface of body 818. A blocking surface 884 extends from stopbutton 882, and includes two elongated aperture 886 each having anoverlapping large bore 888 and small bore 890. When stop button 882 ispressed, blocking surface 884 slides in a slot 892 within body 818,moving along an axis transverse to a longitudinal axis of inserter 800.A pin 894 passes through body 818 and resides within an elongatedchannel 896 within blocking surface 884. In this manner, an extent ofmovement of blocking surface 884 is limited by the dimensions ofelongated channel 896 and pin 894.

One or more springs 898 bear against body 818 and blocking surface 884to thereby urge stop button 882 and blocking surface 884 in an outward,locking direction, whereby stems 820, 822 each pass through a small bore890 portion of an elongated aperture 886. Small bore 890 is sized sothat a sleeve 840 cannot pass therethrough. In this manner, stems 820,822 are retained within body 818. Additionally, stem 820 or 822 cannotpass through spring 844 and sleeve 840 as they are collectively mutuallyengaged by collar 848 and flange 846, requiring that these componentsmust pass through large bore 888 together in order to pass outside ofbody 818.

To remove stems 820, 822, from a secured position stop button 882 ispressed, causing stems 820, 822 to pass from the small bores 890 intothe large bores 888, the latter having a diameter larger than thesleeves 840. Stems 820, 822 are now free to emerge from a proximal end898 of body 818 (FIG. 21B). To urge stems 820, 822 towards proximal end898, slide release assembly 850 is deployed.

More particularly, slide release assembly 850 includes a slide block 852having two apertures 854 each sized to allow a stem 820 or 822 to pass,but sized smaller than sleeve 840. Slide block 852 is connected to atleast one slide button 856 each accessible at a surface of body 818.Slide block 852 passes through at least one slot 858 opening from aninterior of body 818 to an exterior of body 818. extends between twoslide buttons 856. In the embodiment shown in the figures, there are twoslide buttons 856 and two slots 858 on opposing sides of body 818. Assuch, slide button 856 may be moved to cause slide block 852 to bearupon sleeves 840 to push sleeves 840 together with springs 844 and stems820, 822 through large bores 888 and out of body 818.

To further control movement of slide block 852, a detent and detentfollower can be formed between slide release assembly 850 and body 818.As shown in FIGS. 13-14, one or more ball plungers 860 (a spring loadedroller ball) is mounted to slide block 852 or slide buttons 856, and oneor mating detents 862 (FIGS. 12 and 14) is formed in body 818 for eachball plunger 860. Detents 862 can be placed at a location correspondingto stem securing or locking position of slide block 852 (FIG. 14) and astem releasing position of slide block 852 (FIG. 12). Slots 858 can bedimensioned so that the ball 864 of ball plunger 860 bears upon asurface throughout a length of travel of ball plunger 860, to guide andfurther secure slide block 852.

It should be understood that ball plungers 860 can alternatively bemounted upon body 818, and detents 862 can be positioned upon slideblock 852 or slide buttons 856. Other detent following cam structurescan be provided, for example a resilient tab (not shown) in place ofball plunger 860.

Bushings 878 can be provided at a proximal end of each of stems 820,822, sized to correspond with small bore 890 and fabricated of amaterial, such as a polymer, which promotes smooth passage of stems 820,822 through small bore 890.

In an embodiment, implant 5500 together with an inserted portion ofinserter 800 of the disclosure can be configured to be placed into thebody through an endoscopic tube or cannula. Inserter 800 of thedisclosure can be used to implant other types of devices into the body,to be positioned within other joints of the body or elsewhere in thebody, particularly where two parameters of the implanted device must beadjusted.

Inserter 800 can be fabricated using any biocompatible materials ofsufficient strength and durability. If inserter 800 is to be reused, itcan be made with materials that can withstand the intended method ofsterilization. Examples include one or more of titanium, stainlesssteel, titanium alloys, non-titanium metallic alloys, polymericmaterials, plastics, plastic composites, PEEK, ceramic, and elastomericmaterials.

The components of the systems and apparatuses may be integrated orseparated. Moreover. The systems and apparatuses disclosed herein may beperformed by more, fewer, or other components, and methods may includemore, fewer, or other steps. Applicants do not intend any of the claimsto invoke 35 U.S.C. 112(f) unless the words “means for” or “step for”are explicitly used in the particular claim.

All references cited herein are expressly incorporated by reference intheir entirety. It will be appreciated by persons skilled in the artthat the present disclosure is not limited to what has been particularlyshown and described herein above. In addition, unless mention was madeabove to the contrary, it should be noted that all of the accompanyingdrawings are not to scale. There are many different features to thepresent disclosure and it is contemplated that these features may beused together or separately. Thus, the disclosure should not be limitedto any particular combination of features or to a particular applicationof the disclosure. Further, it should be understood that variations andmodifications within the spirit and scope of the disclosure might occurto those skilled in the art to which the disclosure pertains.Accordingly, all expedient modifications readily attainable by oneversed in the art from the disclosure set forth herein that are withinthe scope and spirit of the present disclosure are to be included asfurther embodiments of the present disclosure.

What is claimed is:
 1. A device for inserting and adjusting anintervertebral implant, comprising: a body having a rotatable ring andframe; a tube having a distal end and a proximal end, the tubeconfigured to rotate to engage or release from the implant upon rotationof the rotatable ring; a first stem configured to be disposed in thetube; a second stem configured to be supported by the frame, wherein thefirst stem is configured to rotate to adjust the implant along a firstaxis, and wherein the second stem is configured to rotate to adjust theimplant along a second axis.
 2. The device of claim 1, the distal end ofthe tube being a threaded surface mateable with threads of the implant.3. The device of claim 1, the tube further including a peripheralexternal gear at the proximal end, the rotatable ring having an internalperipheral gear mateable with the peripheral external gear of the tube.4. The device of claim 1, each of the first and second stems including aspring bearing upon the body and the stem to urge the stem away from thebody and into engagement with the implant when the implant is engagedwith the tube.
 5. The device of claim 4, each of the first and secondstems having a sleeve concentrically surrounding the stem within thehandle portion, the spring concentrically surrounding the stem andinside the sleeve, the sleeve and spring retained within the handleportion by a distal and a proximal block.
 6. The device of claim 5, thefirst and second stems releasably engageable from the body by moving atleast the proximal block.
 7. The device of claim 6 wherein the spring isretained upon the stem by a stem collar at a distal end of the springand a flange of the sleeve at a proximal end of the spring, the stem,spring, and collar thereby being mutually connected.
 8. The device ofclaim 5, the proximal block including two elongated openings eachforming an overlapping small bore and large bore, a sleeve each passablethrough a large bore and not a small bore, the proximal block movable toalign each of either the small bores or the large bores with a sleeve.9. The device of claim 8, the distal block slideable within the handleportion to bear upon the sleeve of each stem, and to thereby push therespective sleeve, spring, and stem through the large bore and out ofthe body when the proximal block is moved to align each of the largebores with a sleeve.
 10. The device of claim 8, the distal blockresiliently mounted within the handle portion to align the small boreswith the stems in a resting position, and movable by pressing a buttonformed at an end of the distal block to a release position in which thelarge bores are aligned with the stems.
 11. The device of claim 1,wherein each of the first and second stems are independently rotatable.12. The device of claim 9, a resiliently mounted cam associated with oneof the distal block and the body and a detent associated with the otherof the distal block and the body, the cam and detent releasablyengageable as the distal block is moved to define a locked position anda release position.
 13. The device of claim 12, wherein the cam is aball plunger.
 14. The device of claim 1, the frame including at leasttwo channels, one of the at least two channels supporting the tube,another of the at least two channels supporting the second stem.
 15. Thedevice of claim 1, the handle portion including two proximal apertureseach communicating with a proximal end of a stem.
 16. The device ofclaim 1, the stems being reversibly removable.
 17. A device forinserting and adjusting an intervertebral implant, comprising: a handle;a frame including at least two channels, the frame having a proximal endconnected to the handle and a distal end extending away from the handle;a tube having a distal end and a proximal end, the tube configured torotate to engage or release from the implant; a first stem configured tobe disposed in the tube; a second stem configured to be supported by theframe; the first stem being rotatably and slideably disposed within thetube, the first stem independently rotatable with respect to the tube;the second stem being rotatably and slideably supported by the frame;and a ring rotatably connected to the handle and configured to rotatethe tube by rotation of the ring to engage or disengage from theimplant.
 18. The device of claim 17, each of the first and second stemsincluding a spring bearing upon the handle and the stem to urge the stemaway from the handle portion of the body and into engagement with theimplant when the implant is engaged with the tube.
 19. The device ofclaim 17, the distal end of the tube being a threaded surface mateablewith threads of the implant.
 20. The device of claim 17, the tubefurther including a peripheral external gear at the proximal end, therotatable ring having an internal peripheral gear mateable with theperipheral external gear of the tube.